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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSR110137
Device Problems Failure to Calibrate (2440); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, during machine set up for a navio assisted surgery, the error "handpiece error: verify the handpiece and press dismiss to continue" came on the screen. The navio handpiece could not be calibrated. The procedure was completed with manual instrumentation. It is unknown if this cause a delay in the procedure. The patient was not harmed beyond the reported problem.
 
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Brand NameNAVIO HANDPIECE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13282528
MDR Text Key283960977
Report Number3010266064-2022-00033
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/18/2022 Patient Sequence Number: 1
Treatment
ROB00036-NAVIO SURGICAL SYSTEM INDIA
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